Peer ViolenceNCT03448523
Evaluation of Right To Play's Positive Child and Youth Development Program in Middle Schools in Hyderabad, Pakistan
A study testing Right To Play's Positive Child and Youth Development program in people with Peer Violence and Depression, run by Medical Research Council, South Africa.
Trial summary
This is a RCT conducted with 1752 children in 40 public middle schools in Hyderabad Pakistan with the goal of evaluating the effectiveness of the international non-governmental organisation Right To Play's Positive Child and Youth Development program on reducing peer violence perpetration and victimisation and child… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peer Violence, Depression
- What is being tested?
- Right To Play's Positive Child and Youth Development program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,752 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Schools: single sex, public middle schools in Hyderabad; willing to participate and commit time during the school day, twice a week, to the intervention sessions; having an outside playground or indoor space in which games could be played, and 35 or more students in the grade-6 class
- School student participants: enrolled in grade 6 in one of the study schools; informed consent from parent and child; able to read the national language Urdu or provincial language Sindhi
Who cannot join
- None
About this study
Official title: Evaluation of Right To Play's Positive Child and Youth Development Program: A Cluster Randomised Controlled Trial of a School Play-based Intervention to Prevent Peer Violence and Depression in Hyderabad, Pakistan
This is a RCT conducted with 1752 children in 40 public middle schools in Hyderabad Pakistan with the goal of evaluating the effectiveness of the international non-governmental organisation Right To Play's Positive Child and Youth Development program on reducing peer violence perpetration and victimisation and child depression in a two arm trial where this intervention is compared to a no intervention arm.
Read the detailed description
Peer violence is an important violence exposure for young adolescents and has been linked to later perpetration or experience of violence in intimate relationships. It is an obstacle to learning and may impact school students' mental health. Prevention of peer violence requires an intervention that empowers youth and teaches them empathy and stronger social skills. The non-governmental organisation Right To Play operates in 18 countries and has a flagship programme that is used in all countries that has never been subject to most rigorous evaluation. It is a multi-faceted programme that has at its heart an intervention that is delivered throughout the school year in two 35 minute sessions games following activities from the manual Red Ball Child Play that focus on 4 areas of youth development: physical, cognitive, social, and emotional components. These structural activities are designed to improve critical thinking, confidence and resilience. They are complimented by a range of additional activities including junior leader training for selected promising young leaders, week long summary camps, sports days and activities to engage parents and members of the community. The main intervention is delivered by coaches employed by Right To Play and given a 3 week training initially, with subsequent regular refresher engagement. They are supported by junior leaders in the games after junior leader training. Training to teachers on the intervention is also provided.
A two-arm, cluster randomised controlled trial based in middle schools in Hyderabad, Sindh province, Pakistan is evaluating this intervention. It is being conducted in 40 schools, half are boys schools (20) and half (20) girls'. Twenty of the schools have been randomised to the intervention arm and twenty to the control (delayed intervention) arm. The outcomes will be addressed using quantitative methods with data collected from students in Grade 6 at the start of the trial. These measures will be conducted pre-intervention and 12, and 24 month follow up periods.
- Conditions
- Peer Violence, Depression
- Being tested
- Right To Play's Positive Child and Youth Development program
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right To Play's Positive Child and Youth Development programBehavioural
- Right To Play's Red Ball Child Play manual provided for 60 hours per annum for two years
- Training of junior leaders
- Related play-based activities such as sports days
- Quarterly awareness sessions with community groups and parents
- Summer camps for children
- training of teachers on Right To Play's foundational resources, positive disciplining, and gender and child protection
| Study group | Role | What they receive |
|---|---|---|
| Right To Play's Positive Child and Youth Development program | Experimental | Behavioural intervention Receives: Behavioral: Right To Play's Positive Child and Youth Development program |
| Control | No intervention | No intervention; intervention to be offered after end line assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peer violence victimisation in the past 4 weeks
Mean score on the sixteen questions on peer violence victimisation
Measured: assessment 2 years post-baseline
Peer violence perpetration in the past 4 weeks
Mean score on the sixteen questions on peer violence perpetration
Measured: assessment 2 years post-baseline
Depression
Score on the 28 items Children's Depression Inventory 2 (CDI 2)
Measured: Over last 2 weeks
Secondary outcomes (6)
School performance
Mean score on four items asking about performance in reading, writing, maths and Pakistan studies . Responses per item are 1=fail, 2=average, 3=excellent
Measured: 2 years post baseline
Days of school missed in last 4 weeks
Mean
Measured: 2 years post-baseline
preparations for marriage
Based on two questions "have you been promised for marriage' and (if so) 'has your family started other preparation for your marriage?' An affirmative response to the latter will be compared to a negative response combined with the category of students who have not been promised in marriage.
Measured: 2 years post baseline
Corporal punishment in the past 4 weeks
Mean score across the 6 questions
Measured: 2 years post baseline
Physical punishment at home in past 4 weeks
Based on two items with four response categories. The mean score will be calculated.
Measured: 2 years post baseline
Gender attitudes (13 items measuring acceptability of spousal violence, girls schooling, male respect for women in decision-making and appropriateness of women's participation)
Mean score
Measured: 2 years post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Dec 2015
- Primary completion9 Mar 2018 (estimated)
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peer ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label, randomised, efficacy study
- Masking
- None (open label)
- Enrolment
- 1,752 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council, South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University, Texas Woman's University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448523
- Sponsor's protocol ID
- EC025-8/2015
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will me made available open access but it will not be individual participant data. The details are still being worked out
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Right To Play's Positive Child and Youth Development Program: A Cluster Randomised Controlled Trial of a School Play-based Intervention to Prevent Peer Violence and Depression in Hyderabad, Pakistan
- ClinicalTrials.gov ID
- NCT03448523
- Acronym / sponsor ID
- EC025-8/2015
- Conditions
- Peer Violence, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,752 participants (actual)
- Lead sponsor
- Medical Research Council, South AfricaUniversity, hospital or other
- Collaborators
- Aga Khan University, Texas Woman's University
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 9 Mar 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a RCT conducted with 1752 children in 40 public middle schools in Hyderabad Pakistan with the goal of evaluating the effectiveness of the international non-governmental organisation Right To Play's Positive Child and Youth Development program on reducing peer violence perpetration and victimisation and child depression in a two arm trial where this intervention is compared to a no intervention arm.
Detailed description
Peer violence is an important violence exposure for young adolescents and has been linked to later perpetration or experience of violence in intimate relationships. It is an obstacle to learning and may impact school students' mental health. Prevention of peer violence requires an intervention that empowers youth and teaches them empathy and stronger social skills. The non-governmental organisation Right To Play operates in 18 countries and has a flagship programme that is used in all countries that has never been subject to most rigorous evaluation. It is a multi-faceted programme that has at its heart an intervention that is delivered throughout the school year in two 35 minute sessions games following activities from the manual Red Ball Child Play that focus on 4 areas of youth development: physical, cognitive, social, and emotional components. These structural activities are designed to improve critical thinking, confidence and resilience. They are complimented by a range of additional activities including junior leader training for selected promising young leaders, week long summary camps, sports days and activities to engage parents and members of the community. The main intervention is delivered by coaches employed by Right To Play and given a 3 week training initially, with subsequent regular refresher engagement. They are supported by junior leaders in the games after junior leader training. Training to teachers on the intervention is also provided.
A two-arm, cluster randomised controlled trial based in middle schools in Hyderabad, Sindh province, Pakistan is evaluating this intervention. It is being conducted in 40 schools, half are boys schools (20) and half (20) girls'. Twenty of the schools have been randomised to the intervention arm and twenty to the control (delayed intervention) arm. The outcomes will be addressed using quantitative methods with data collected from students in Grade 6 at the start of the trial. These measures will be conducted pre-intervention and 12, and 24 month follow up periods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label, randomised, efficacy study
| Arm | Type | Receives |
|---|---|---|
| Right To Play's Positive Child and Youth Development program | Experimental | Behavioral: Right To Play's Positive Child and Youth Development programBehavioural intervention |
| Control | No intervention | –No intervention; intervention to be offered after end line assessment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Schools: single sex, public middle schools in Hyderabad; willing to participate and commit time during the school day, twice a week, to the intervention sessions; having an outside playground or indoor space in which games could be played, and 35 or more students in the grade-6 class
- School student participants: enrolled in grade 6 in one of the study schools; informed consent from parent and child; able to read the national language Urdu or provincial language Sindhi
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right To Play's Positive Child and Youth Development program1. Right To Play's Red Ball Child Play manual provided for 60 hours per annum for two years 2. Training of junior leaders 3. Related play-based activities such as sports days 4. Quarterly awareness sessions with community groups and parents 5. Summer camps for children 6. training of teachers on Right To Play's foundational resources, positive disciplining, and gender and child protection | Behavioural | Right To Play's Positive Child and Youth Development program |
Primary outcome
Peer violence victimisation in the past 4 weeks
Time frame: assessment 2 years post-baseline
Mean score on the sixteen questions on peer violence victimisation
Peer violence perpetration in the past 4 weeks
Time frame: assessment 2 years post-baseline
Mean score on the sixteen questions on peer violence perpetration
Depression
Time frame: Over last 2 weeks
Score on the 28 items Children's Depression Inventory 2 (CDI 2)
6 secondary outcomes
School performance
Time frame: 2 years post baseline
Days of school missed in last 4 weeks
Time frame: 2 years post-baseline
preparations for marriage
Time frame: 2 years post baseline
Corporal punishment in the past 4 weeks
Time frame: 2 years post baseline
Physical punishment at home in past 4 weeks
Time frame: 2 years post baseline
Gender attitudes (13 items measuring acceptability of spousal violence, girls schooling, male respect for women in decision-making and appropriateness of women's participation)
Time frame: 2 years post baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: No. The data will me made available open access but it will not be individual participant data. The details are still being worked out
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Peer Counselling to Reduce Psychological Distress and Exposure to Violence Among Sexual and Gender Minorities
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Recruiting
Trauma-Informed Peer Aggression and Dating Violence Prevention for Preteens Receiving Intensive Mental Health Services
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Right To Play's Positive Child and Youth Development program in people with Peer Violence and Depression, run by Medical Research Council, South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peer violence victimisation in the past 4 weeks (time frame: assessment 2 years post-baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.